restor3d MTP
- Primary DI
- 00840097505244
- Brand
- restor3d MTP
- Company
- Restor3d
- Model
- 1103-161620
- Device description
- CoCr MTP Implant, Large
- Published
- 2023-04-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K201393 | 000 | restor3d MTP Implant | Restor3D, Inc. | 2022-05-25 | KWD |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840097505244 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Partial metatarsophalangeal joint prosthesis | An implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. |
Regulatory Flags
- DUNS number
- 080819836
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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